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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Ostia, Aorto-Saphenous Vein
510(k) Number K971966
Device Name CORONARY VEIN GRAFT TAG MARKER
Applicant
MED-EDGE, INC.
1843 PINEHURST DR.
CLEMMONS,  NC  27012
Applicant Contact STEVE OWENBY
Correspondent
MED-EDGE, INC.
1843 PINEHURST DR.
CLEMMONS,  NC  27012
Correspondent Contact STEVE OWENBY
Classification Product Code
KPK  
Date Received05/28/1997
Decision Date 01/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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